HPLC测定二氟泼尼酯眼用乳剂的含量  

Determination of the Difluprednate Ophthalmic Emulsion by HPLC

作　　者：王金虎 郭文建 

机构地区：[1]山东省医药工业研究所,山东济南250101 [2]山东省化药重点室验室,山东济南250101

出　　处：《食品与药品》2012年第11期428-430,共3页Food and Drug

摘　　要：建立高效液相色谱法测定二氟泼尼酯眼用乳剂中二氟泼尼酯的含量。方法采用SHIMADZU VP-ODS C18(150mm×4.6 mm,5μm)色谱柱,流动相为甲醇-水(52:48),检测波长240 nm,流速1.0 mL/min,柱温35℃。结果二氟泼尼酯在2.034-20.34μg/mL浓度范围内与峰面积有良好的线性关系,平均回收率98.80%。结论此方法结果简便,准确,重复性好,可以用于二氟泼尼酯眼用乳剂的质量控制。Objective To establish an HPLC method for the determination of the difluprednate in difluprednate ophthalmic emulsion. Methods SHIMADZU VP-ODS C18 column （150 mm×4.6 mm, 5 μm） was adopted, the methanol-water （52：48） was used as mobile phase, the detection wavelength was 240 nm, the flow rate was 1.0 mL/ min, and the column temperature was 40 ℃. Results The linear range of difluprednate was 2.034- 20.34 μg/mL, the average recovery rate was 98.80%. Conclusion The method was simple, accurate and reproducible, can be used for quality control of difluprednate ophthalmic emulsion.

关 键 词：高效液相色谱法 二氟泼尼酯 含量测定 

分 类 号：R927.2[医药卫生—药学]